Job Title: Software Quality EngineerJob Description
We are seeking a Software Quality Engineer with expertise in authoring NonProduct Software Validation quality records for Quality Management Systems. The ideal candidate will ensure compliance with applicable regulations, standards, and corporate governing procedures, with a focus on systems such as Training, Document Control, PLM, and ERP.
Responsibilities

+ Author NonProduct Software Validation quality records in accordance with regulations, standards, and corporate procedures.

+ Act as a subject matter expert for 21 CFR Part 820, ISO standards, and 21 CFR Part 11/Annex 11.

+ Evaluate quality records for compliance and deliver constructive feedback to authors.

+ Coach coworkers on regulatory compliance and applicable governing procedures.

+ Perform approver roles including Change Initiator, Quality Representative, Business Process Owner, and Technical System Owner.

+ Manage...